Evaluation of the Effect of a Cranberry Formulation in Reducing the Inflammatory State and Improving the Management of Symptoms in Patients with Symptomatic Uncomplicated Diverticular Disease: A Prospective, Open-Label, Single-Arm, Multi-Center, Pilot Study

TL;DR

A cranberry supplement reduced inflammation and symptoms in patients with a digestive condition called SUDD in a small pilot study.

Contribution

A gastroresistant cranberry formulation was tested for its anti-inflammatory and symptom-relieving effects in SUDD patients.

Findings

Fecal calprotectin levels significantly decreased after 4 weeks of cranberry treatment and remained reduced after 8 weeks.

SUDD symptoms, measured by VAS, were significantly reduced both during and after treatment.

Results were consistent in both ITT and PP analyses.

Abstract

Background/Objectives: Low-grade inflammation and microbial imbalance have been thought to play a role in the pathogenesis of Symptomatic Uncomplicated Diverticular Disease (SUDD). We aimed to assess the efficacy of a cranberry formulation in reducing the inflammatory state of the colon and symptoms in SUDD patients. Methods: Twenty patients were enrolled in a prospective, multi-center, open-label, pilot study. We enrolled SUDD patients in whom fecal calprotectin (FC) was assessed at baseline and during the follow-up, with a baseline value ≥ 50 µg/g. Patients were treated with a gastroresistant formulation of cranberry (Vaccinium macrocarpon), one tablet/day for 4 weeks, followed by an 8-week observation period. The primary endpoint was to assess the efficacy of this gastroresistant cranberry formulation in reducing the inflammatory state of the colon by FC assessment. The secondary main endpoint was to assess the impact of this formulation on SUDD symptoms (assessed by the Visual Analog Scale, VAS). Intention-to Treat (ITT) and Per-Protocol (PP) analyses were performed. Results: At baseline, the mean FC value was 110 ± 118 μg/g; it was 72 ± 24 μg/g and 82 ± 19 μg/g after 4 weeks of treatment, and after a further 8 weeks of observation, it was significantly reduced on both ITT (p = 0.0001) and PP (p = 0.001). About the secondary main endpoint (namely symptoms of SUDD), the mean values according to the VAS were reduced significantly both at the end of the treatment and after 8 weeks post treatment. Conclusions: This gastroresistant formulation of cranberry may be able to reduce inflammation and symptoms in SUDD patients. Furthermore, large studies have to confirm these preliminary and promising results.

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